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Director, Process Engineering - Head of Internal Operations

Gilead Sciences

Foster City, CA; El Segundo, CA; Oceanside, CA; Thousand Oaks, CAHybridPosted 1 day ago$205,615.00 - $292,710.00
Full TimeDirector & AboveManufacturing & CMCPharmaceutical
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Summary

Gilead Sciences, Inc. is a leading American biopharmaceutical company headquartered in Foster City, California, that specializes in researching, developing, and commercializing innovative medicines for life-threatening diseases. Founded in 1987, Gilead has grown into a global healthcare leader with approximately 17,600 employees worldwide. The company's primary therapeutic focus areas include HIV/AIDS, viral hepatitis (hepatitis B and C), oncology, inflammation, and respiratory diseases. Gilead is renowned for its groundbreaking antiviral therapies, including Sovaldi and Harvoni for hepatitis C, and its comprehensive portfolio of HIV treatments such as Truvada, Atripla, and Biktarvy. The company also developed Veklury (remdesivir) for COVID-19 treatment. Gilead operates as a publicly traded company on the NASDAQ (GILD) and is a component of both the Nasdaq-100 and S&P 100 indices. Through strategic acquisitions like Kite Pharma and Immunomedics, Gilead has expanded into cell therapy and oncology, demonstrating its commitment to advancing medical science and improving patient outcomes globally.

Job description

Key Responsibilities

Strategic and Functional Leadership

  • Set the Internal Operations strategy, priorities, governance, and resource plan in alignment with Network MSAT, Process Development and Manufacturing-site needs, and enterprise objective.
  • Lead project leaders and technical SMEs by establishing clear accountabilities, decision rights, and escalation pathways.
  • Build a capable, inclusive, and accountable team; develop successors and strengthen project leadership, process stewardship, and investigation capabilities.
  • Serve as the primary connection between Network MSAT and manufacturing sites, translating site priorities and technical risks into network actions.
  • Define and monitor practical measures for portfolio delivery, process-document maturity, investigation effectiveness, risk reduction, and realized business value.
  • Advise the Head of Network MSAT and senior stakeholders on operational risk, organizational capability, deploy resources and investments, as required, to deliver near- and long-term objectives, in a scalable manner.
  • Provide leadership during high-impact manufacturing events, risks, regulatory challenges, and technical investigations; with clear executive communication.

Global Project and Portfolio Leadership

  • Accountable for leading a focused portfolio of highly-complex, cross-site MSAT projects with clear outcomes, milestones, resources, risks, and governance.
  • Partner with cGML and Process Design to reflect lessons learned and improvements made to our commercial operations, which has strengthened process robustness, operational readiness, and cost effectiveness.
  • Integrate project execution with validation, regulatory, supply, and site implementation plans to support predictable delivery.

Process Stewardship and Standardization

  • Own the governance and lifecycle of standardized global process documentation, including enhanced Process Description Reports (ePDRs).
  • Lead global MSAT impact assessments for change controls and lifecycle changes to maintain cross-site consistency and reduce process drift.
  • Expand process stewardship to pFMEAs, control strategy linkages, reusable technical knowledge, and effective handoffs into routine operations.

Global Investigations and Technical Problem Solving

  • Lead complex cross-site investigations involving process performance, critical quality attributes, comparability, assay variability, and recurring manufacturing issues.
  • Establish a consistent global investigation framework, including trigger and escalation criteria, a practical playbook, analytical tools, and lessons learned.
  • Ensure investigation conclusions are scientifically sound and translated into sustainable process improvements or lifecycle actions.

Requirements

  • Bachelor's degree in chemical engineering, biochemical engineering, biotechnology, biochemistry, biology, chemistry, or a related scientific/engineering discipline with 12+ years of relevant experience; OR a Master's degree with 10+ years of relevant experience; OR a PhD with 8+ years of relevant experience
  • Significant people-leadership experience, including leading multidisciplinary technical teams in a regulated biopharmaceutical manufacturing environment
  • Demonstrated experience leading complex, cross-functional programs across multiple sites or business units, including strategy, governance, prioritization, resource planning, risk management, and delivery through others
  • Demonstrated leadership of global or cross-site investigations involving process performance trends, critical quality attributes, comparability, assay or method variability, and product-impact assessment
  • Demonstrated experience supporting cGMP manufacturing, process lifecycle management, technical investigations, change impact assessment, CAPA, and inspection readiness
  • Proven ability to navigate ambiguity, apply systems thinking, influence senior stakeholders without direct authority, and translate technical risks into clear business decisions
  • Excellent written and verbal communication skills, including the ability to communicate with senior leaders and represent the organization in high-stakes technical and operational forums
  • Strong relationship-building and influencing skills, with the ability to align senior stakeholders and lead effectively without direct authority
  • Clear, concise, and audience-appropriate communication skills, including the ability to translate complex technical topics into business decisions
  • High learning agility, sound judgment, and comfort operating through ambiguity, changing priorities, and incomplete information
  • Demonstrated emotional intelligence, active listening, constructive challenge, and conflict-resolution skills
  • Strong organizational and prioritization skills, with the ability to balance urgent operational needs and longer-term capability development

Benefits

  • Medical, Dental & Vision
  • Life Insurance
  • Discretionary Annual Bonus
  • Stock-Based Long-Term Incentives
  • Paid Time Off

Company overview

Gilead Sciences, Inc. is a leading American biopharmaceutical company headquartered in Foster City, California, that specializes in researching, developing, and commercializing innovative medicines for life-threatening diseases. Founded in 1987, Gilead has grown into a global healthcare leader with approximately 17,600 employees worldwide. The company's primary therapeutic focus areas include HIV/AIDS, viral hepatitis (hepatitis B and C), oncology, inflammation, and respiratory diseases. Gilead is renowned for its groundbreaking antiviral therapies, including Sovaldi and Harvoni for hepatitis C, and its comprehensive portfolio of HIV treatments such as Truvada, Atripla, and Biktarvy. The company also developed Veklury (remdesivir) for COVID-19 treatment. Gilead operates as a publicly traded company on the NASDAQ (GILD) and is a component of both the Nasdaq-100 and S&P 100 indices. Through strategic acquisitions like Kite Pharma and Immunomedics, Gilead has expanded into cell therapy and oncology, demonstrating its commitment to advancing medical science and improving patient outcomes globally.

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